Transcorneal Electrical Stimulation Therapy for Retinal Disease

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ClinicalTrials.gov Identifier: NCT00804102

Recruitment Status : Completed

First Posted : December 8, 2008

Last Update Posted : May 4, 2012

Sponsor:

Information provided by (Responsible Party):

Okuvision GmbH

Study Description

Brief Summary:

Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.

Condition or disease	Intervention/treatment	Phase
Retinitis Pigmentosa Macula Off Primary Open Angle Glaucoma Hereditary Macular Degeneration Treated Retina Detachment Retinal Artery Occlusion Retinal Vein Occlusion Non-Arthritic-Anterior-Ischemic Optic-Neuropathy Hereditary Autosomal Dominant Optic Atrophy Dry Age Related Macular Degeneration Ischemic Macula Edema	Device: Transcorneal Electrical Stimulation Device: DTL-electrode attached without energy	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study
Study Start Date :	January 2008
Actual Primary Completion Date :	April 2011
Actual Study Completion Date :	April 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Age-related macular degeneration Cone-rod dystrophy Early-onset glaucoma Optic atrophy type 1 Retinitis pigmentosa

MedlinePlus related topics: Retinal Disorders

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome Anterior Ischemic Optic Neuropathy Retinitis Pigmentosa Cone-rod Dystrophy Cone-rod Dystrophy 2 Dominant Optic Atrophy Optic Atrophy 1

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Retinitis pigmentosa	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Macula off condition after treatment of retinal detachment	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Primary open angle Glaucoma	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Hereditary Macular Degeneration	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Treated Retina detachment	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Retinal Artery Occlusion	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Retinal Vein Occlusion	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Hereditary autosomal dominant Optic atrophy	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: dry Age-related Macular Degeneration	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Ischemic Macula edema	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Sham Comparator: Non-stimulated	Device: DTL-electrode attached without energy DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.

Outcome Measures

Primary Outcome Measures :

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Exclusion Criteria:

Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
Age above 99 years

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804102

Sponsors and Collaborators

Okuvision GmbH

Investigators


Principal Investigator:	Florian Gekeler, MD, Prof	University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany

More Information

Publications of Results:

Schatz A, Röck T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Naycheva L, Schatz A, Röck T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.


Responsible Party:	Okuvision GmbH
ClinicalTrials.gov Identifier:	NCT00804102 History of Changes
Other Study ID Numbers:	EST-2008
First Posted:	December 8, 2008 Key Record Dates
Last Update Posted:	May 4, 2012
Last Verified:	May 2012

Keywords provided by Okuvision GmbH:


Retinitis pigmentosa Macula off Primary open angle Glaucoma Hereditary Macular Degeneration Treated Retina detachment Retinal Artery Occlusion	Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy Hereditary autosomal dominant Optic atrophy dry Age-related Macular Degeneration Ischemic Macula edema

Additional relevant MeSH terms:


Ischemia Glaucoma Macular Degeneration Atrophy Glaucoma, Open-Angle Retinal Vein Occlusion Retinitis Retinitis Pigmentosa Cone-Rod Dystrophies Optic Nerve Diseases Retinal Diseases Optic Neuropathy, Ischemic Retinal Artery Occlusion Optic Atrophy Optic Atrophy, Autosomal Dominant	Retinal Detachment Pathologic Processes Ocular Hypertension Eye Diseases Retinal Degeneration Pathological Conditions, Anatomical Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Eye Diseases, Hereditary Retinal Dystrophies Genetic Diseases, Inborn Cranial Nerve Diseases

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